A Phase II Study of Spinal Radiosurgery (RAD0408)
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|ClinicalTrials.gov Identifier: NCT00573872|
Recruitment Status : Completed
First Posted : December 14, 2007
Results First Posted : October 20, 2017
Last Update Posted : December 5, 2017
|Condition or disease||Intervention/treatment||Phase|
|Neoplasm Arteriovenous Malformations||Radiation: Radiosurgery||Not Applicable|
Optimal radiation plan is generated that treats the tumor (CTV) and spares normal tissue, especially the spinal cord. Motion and QA study will determine intrafraction motion for phase II portion of the study.
Dose prescription to tumor is based upon maximal dose received by 0.5 cc of spinal cord and whether patient has had prior radiation therapy to that area:
Phase I - Motion and QA Study: 20-25 Gy in 5 fractions/10-20 patients/previous RT = <50% CTV dose/No previous RT = <80% CTV dose.
Phase II - 9-24 Gy in 1 fraction/30 total in order to have 20 evaluable patients (15 patients with prior RT and 15 without prior RT/previous RT = 8 Gy/No previous RT = 10 Gy.
# Motion and QA study will treat CTV to 20-25 Gy in 5 fractions to study intrafraction motion for QA of single fraction administration. This will define treatment margins for single fraction radiosurgery.
- greater than six months since completion of RT
- at least 20 Gy, but no more than 50 Gy
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||43 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Study of Spinal Radiosurgery|
|Actual Study Start Date :||April 2005|
|Actual Primary Completion Date :||September 2016|
|Actual Study Completion Date :||September 2016|
Experimental: Spinal Radiosurgery
Patients will be fitted in a custom immobilization device. A CT simulation scan will then be performed to pinpoint intended radiosurgery target producing a computer optimized radiation plan to be confirmed by planning radiation physicist. Patient will then be placed in their immobilization device and aligned with the treatment planning position. Patient then receives radiosurgery. Treatment delivery will be divided into components of 3-5Gy with repeat CT based localization in between each of these components. For all patients, a nominal prescription dose of 24Gy will be entered into the tomotherapy cost function. Once the plan that provides maximal spinal sparing has been generated, the plan will be renormalized to produce no more than 8Gy (prior RT) or 10Gy (no prior RT) to 0.5cc of spinal cord by dividing the single fraction treatment into fractions of 3-5Gy.
Phase I: 20-25 Gy in 5 fractions
Phase II: 9-24 GY in 1 fraction
- Number of Participants With Palliative Response (Pain or Relief of Neurologic Symptoms) From Single Fraction Radiosurgery Delivered With Tomotherapy [ Time Frame: 2 years ]Physician's subjective report of palliative pain relief. The maximal benefit patient received (best response) is reported. Scale is pain described as "worse", "stable", "better", or "completely resolved". In the reporting "better" or "completely resolved" indicates response to treatment.
- Assess the Acute and Late Toxicity of Spinal Radiosurgery [ Time Frame: 2 years ]CTCAE version 3. Acute toxicity will be recorded if toxicity occurs early phase or within 3 months, and late toxicity would be any toxicity that follows those 3 months.
- Number of Participants With Lack of Tumor Growth at Last Follow-up [ Time Frame: 2 years ]Lack of tumor growth by CT or MRI at last follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00573872
|United States, Alabama|
|University of Alabama at Birmingham/The Kirklin Clinic at Acton Road|
|Birmingham, Alabama, United States, 35233|
|Principal Investigator:||John B. Fiveash, M.D.||University of Alabama at Birmingham|